ASTM International

Standard Test Method for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
 N F2385

Annotation

This practice provides guidance for the measurement of the relative displacement of the femoral head and acetabular component that result from wear and deformation occurring at the articular interface of a total hip replacement from sequential clinical radiographs.

This practice is primarily intended for use in evaluating patients receiving THRs composed of a polyethylene acetabular component articulating against a metal or ceramic femoral head.

So-called hard-on-hard articulations such as metal-onmetal and ceramic-on-ceramic THRs are not intended to be directly addressed.

This practice will focus on computer assisted computational methodologies for measuring relative displacements over time but not to the exclusion of other methodologies.

This practice describes methods for conducting a radiographic wear/creep study utilizing various computational methods and is not intended to promote or endorse a particular method.

It is not the intent of this practice to provide detailed instructions in the use of the various computational methods, which is contained in the respective user manuals.

It is the intent of this practice to enable comparisons of relative displacements occurring in groups of patients receiving different formulations of bearing materials. It must be recognized, however, that there are many possible variations in the in vivo conditions. A single clinical study may not be universally representative.

This practice is not intended to be a performance standard. It is the responsibility of the user of this practice to characterize the safety and effectiveness of the prosthesis under evaluation.